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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. OBTRYX TRANSVAGINAL MEDICAL SLING; MESH, SURGICAL, SYNTHETIC UROGYNECOLOGIC FOR STRESS URINARY INCONTINENCE, RETROP
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BOSTON SCIENTIFIC CORP. OBTRYX TRANSVAGINAL MEDICAL SLING; MESH, SURGICAL, SYNTHETIC UROGYNECOLOGIC FOR STRESS URINARY INCONTINENCE, RETROP Back to Search Results
Device Problems Material Fragmentation (1261); Difficult to Remove (1528)
Patient Problems Perforation (2001); Ambulation Difficulties (2544); Device Embedded In Tissue or Plaque (3165)
Event Date 11/17/2013
Event Type  Injury  
Event Description
A mesh sling was placed and subsequently broke apart in my body, (boston scientific, obtryx transvaginal sling).I have a hard, sharp piece of something sharp cutting through my vaginal tissue.I have had 2 removals which resulted in my being malformed, but drs cannot get the mesh out.I have been mostly bedridden and now home bound since 2013.I was (b)(6) in school and ran 3-5 days a week.I am now unable to walk properly and my children have had to grow up without a mom.I have been to specialists from (b)(6) to (b)(6), to (b)(6).Multiple physical therapists and drs are able to feel the sling through my tissue.An ultrasound in 2017 showed the sling still present in spite of 2 removals.Mesh made from polypropylene need to be taken off the market.How can we preach getting plastic out of the oceans while intentionally putting plastic mesh inside of humans? fda safety report id# (b)(4).
 
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Brand Name
OBTRYX TRANSVAGINAL MEDICAL SLING
Type of Device
MESH, SURGICAL, SYNTHETIC UROGYNECOLOGIC FOR STRESS URINARY INCONTINENCE, RETROP
Manufacturer (Section D)
BOSTON SCIENTIFIC CORP.
MDR Report Key9410124
MDR Text Key169207469
Report NumberMW5091400
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age44 YR
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